patient safety in radiation therapy - hps chaptershpschapters.org/src/tobin hyman srs hps...
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Patient Safety in Radiation Therapy:
A History of Errors & A Methodology to Prevent Them
Monday, April 8, 2013
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About the speaker:
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About the speaker:
• Tobin Hyman, MS, DABR
• BS, Health Physics, Francis Marion College, 1992
• MS, Health Physics, University of Florida, 1994
• Senior Medical Physicist, MRMC
• Practicing MP since 1995
• Physics surveyor for the ROPA program of the ACR
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Disclosures
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Disclosures
• sole proprietor of Carolina Physics, LLC
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About MRMC Radiation Therapy:
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About MRMC Radiation Therapy:
• MRMC serves NE South Carolina and Southern North Carolina
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About MRMC Radiation Therapy:
• MRMC serves NE South Carolina and Southern North Carolina
• Treat approximately 750-800 new patients per year
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About MRMC Radiation Therapy:
• MRMC serves NE South Carolina and Southern North Carolina
• Treat approximately 750-800 new patients per year
• Techniques include 3D conformal, IMRT, HDR (brachy), and LDR (brachy)
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About MRMC Radiation Therapy:
• MRMC serves NE South Carolina and Southern North Carolina
• Treat approximately 750-800 new patients per year
• Techniques include 3D conformal, IMRT, HDR (brachy), and LDR (brachy)
• 2014 will bring SRS/SRT and SBRT as treatment techniques
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About MRMC Radiation Therapy:
• MRMC serves NE South Carolina and Southern North Carolina
• Treat approximately 750-800 new patients per year
• Techniques include 3D conformal, IMRT, HDR (brachy), and LDR (brachy)
• 2014 will bring SRS/SRT and SBRT as treatment techniques
• Accredited by the American College of Radiology ROPA
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Disclaimer
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Disclaimer
• The historical errors presented are not an attempt to “beat up” on the equipment vendors
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Disclaimer
• The historical errors presented are not an attempt to “beat up” on the equipment vendors
• The historical errors presented are not an attempt to “condemn or belittle” the medical physicists or personnel involved
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Disclaimer
• The historical errors presented are not an attempt to “beat up” on the equipment vendors
• The historical errors presented are not an attempt to “condemn or belittle” the medical physicists or personnel involved
• Presentation and discussion of these incidents are provided to establish a “burning platform” for change within clinical practice, and to highlight the use of the P-FMEA
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Learning Objectives:
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Learning Objectives:• Introduction to the Radiation Therapy Process
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Learning Objectives:• Introduction to the Radiation Therapy Process
• Review of the rate of errors within Radiation Therapy (literature)
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Learning Objectives:• Introduction to the Radiation Therapy Process
• Review of the rate of errors within Radiation Therapy (literature)
• What is considered a “Misadministration” in SC?
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Learning Objectives:• Introduction to the Radiation Therapy Process
• Review of the rate of errors within Radiation Therapy (literature)
• What is considered a “Misadministration” in SC?
• History & Taxonomy of Radiation Therapy Errors - “What We Know”
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Learning Objectives:• Introduction to the Radiation Therapy Process
• Review of the rate of errors within Radiation Therapy (literature)
• What is considered a “Misadministration” in SC?
• History & Taxonomy of Radiation Therapy Errors - “What We Know”
• Introduction to Lean Healthcare Principles
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Learning Objectives:• Introduction to the Radiation Therapy Process
• Review of the rate of errors within Radiation Therapy (literature)
• What is considered a “Misadministration” in SC?
• History & Taxonomy of Radiation Therapy Errors - “What We Know”
• Introduction to Lean Healthcare Principles
• Introduction & History of the P-FMEA
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Learning Objectives:• Introduction to the Radiation Therapy Process
• Review of the rate of errors within Radiation Therapy (literature)
• What is considered a “Misadministration” in SC?
• History & Taxonomy of Radiation Therapy Errors - “What We Know”
• Introduction to Lean Healthcare Principles
• Introduction & History of the P-FMEA
• Application of the P-FMEA to Radiation Therapy
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Learning Objectives:• Introduction to the Radiation Therapy Process
• Review of the rate of errors within Radiation Therapy (literature)
• What is considered a “Misadministration” in SC?
• History & Taxonomy of Radiation Therapy Errors - “What We Know”
• Introduction to Lean Healthcare Principles
• Introduction & History of the P-FMEA
• Application of the P-FMEA to Radiation Therapy
• Future Applications of the P-FMEAMonday, April 8, 2013
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The Radiation Therapy Process - Global View
Patient Assessment
Decision toTreat
Prescription Positioning &Immobilization
Simulation, Imaging, &Volume
Determination
Planning
Commissioning
TreatmentData
TransferPatient Setup
TreatmentDelivery
Treatment Verification &Monitoring
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How Many Errors are Occurring in Radiation Therapy?
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How Many Errors are Occurring in Radiation Therapy?
• 2008 World Health Organization (WHO) published the “Radiotherapy Risk Profile”
• retrospective review of 30 years of reported radiation therapy incidents
• findings included:
• from 1976 to 2007, 3125 patients were reported to be affected by radiotherapy incidents that led to adverse events (38 reported fatalities; differs from the 53 reported in this presentation)
• from 1992 to 2007, 4616 “near misses” (incident that did not cause harm) were reported
• Total of 7741 “events”
• weaknesses/flaws? result of investigations of major events, relates mainly to developed countries
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Patient Assessment
Decision To Treat
Prescription
Positioning & Immobilization
Simulation, Imaging & Volume Determination
Commissioning
Planning
Treatment Data Transfer
Patient Setup
Treatment Delivery
Treatment Verification & Monitoring
Multiple Stages
0 750 1500 2250 3000
2008 WHO Report - All Incidents
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Patient Assessment
Decison To Treat
Prescription
Positioning & Immobilization
Simulation, Imaging & Volume Determination
Commissioning
Planning
Treatment Data Transfer
Patient Setup
Treatment Delivery
Treatment Verification & Monitoring
0 5 10 15 20
2008 WHO Report - Fatalities
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How Many Errors are Occurring in Radiation Therapy?
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How Many Errors are Occurring in Radiation Therapy?
• New York Times reported:
• between 2001-2008, 621 events were reported in New York State
• most were minor, however...
• 133 reported incidents of devices being left out or wrongly positioned (causation of 2 fatalities and a third incident of over-dose)
• 284 reported incidents were geometric miss
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How Many Errors are Occurring in Radiation Therapy?
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How Many Errors are Occurring in Radiation Therapy?
• in 2005, Eric Klein, et. al., (Washington University, St. Louis, MO) reported:
• 103 “events” in 3964 (2.5% incidence rate per course) courses of therapy initiated (over a 30-month period)
• stratified each error type in terms of frequency, longevity, and dosimetric impact (low, medium, high)
• 76 of the 103 (74%) were categorized as >/= medium in terms of dosimetric impact
• Was this the “first” FMEA in the Radiotherapy Arena?
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Errors in Radiation Therapy - Handicaps
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Errors in Radiation Therapy - Handicaps• Lack of a national database
• Voluntary reporting
• Lack of reporting structure for incidents and near misses
• Dissemination of events/data to other parties
• “Knee-jerk” response to errors - not resolving the “root cause” - we all jump to box 5
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SCDHEC Misadministration - defined
• South Carolina Department of Health and Environmental Control defines a therapy “Misadministration” as (RHB 9.153):
• Radiation delivered to the wrong patient
• Radiation delivered to the wrong site
• Radiation delivered with the wrong mode of treatment
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SCDHEC Misadministration - defined
• Performance of a therapeutic procedure other than that ordered by the prescribing physician
• Error in calibration, time of exposure, or treatment geometry that results in a calculated total dose > the total prescribed treatment dose by more than 20%
• 3 fractions or less > 10%
• Weekly treatment dose exceeds weekly prescribed dose by 30% or more
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RT Errors - Historical
• Description of the incident
• Tobin’s Taxonomy
• Equipment Design
• Process
• Human Error
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RT Errors - Historical• Therac-25 (TX, W, Canada)
• 1982-1990
• 3 fatalities; 4 others with severe or debilitating injuries
• treatment programming change resulted in electron beam at x-ray tube currents - dose > 40Gy
• manufacturers response was “slow”
• Taxonomy - Equipment Design
• photo courtesy of Fritz Hager
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RT Errors - Historical• Incorrect Linac Repair (Spain)
• 1990
• 15 fatalities (most within 1 year; lung & spinal cord injury)
• Repair of accelerator led to 36MeV electron beam delivery regardless of console input
• Physics did not verify operation after maintenance
• Taxonomy - Process, Human Error
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RT Errors - Historical• Error in the calculation of the dose rate of a Co-60
teletherapy unit (Costa Rica)
• 1996
• 13 fatalities (varies by report from 4-17)
• value of 0.3min interpreted as 30 seconds (rather than 18 seconds)
• 73% overdose (including patients from the children’s hospital)
• side effects included ulceration, bleeding, epilation, and anemia
• Taxonomy - Process, Human Error
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RT Errors - Historical• TPS modification - block
entry (Panama)
• 2000
• 17 fatalities from radiation overexposure
• limitations in the TPS with regards to block entry led to 20-100% overdose (treatment times calculated incorrectly)
• Taxonomy - Process, Human Error
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RT Errors - Historical• Machine Malfunction (Poland)
• 2001
• 5 reported overdoses
• Power outage led to a burned out fuse on a control board for the accelerator; failure of the interlock circuit governing this CB resulted in the dose rate increasing five-fold when returned to service; patients reported “itching and burning” of the skin following treatment prompting staff to cease use of the equipment
• 3 patients received 60 to 80 Gy
• Taxonomy - Process
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FIG. 21. Patient 4 on 30 November 2001: CT scan of thorax showing a large pleuraleffusion.
FIG. 22. Patient 4 on 1 December 2001: Severe skin changes following a radiation burn.The wound covers an area of 14 cm ! 8 cm; in its centre lies an ulcer of full thicknesscovering an area of 5 cm ! 4 cm.
Severe skin changes following a radiation burn
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all the thickness of the left chest wall in the internal two thirds of the electronfield, and severe superinfection by pseudomonas aeruginosa. The beating heartof Patient 4 was visible in the depth of the wound. The status of the local injuryis shown in Fig. 23.
Patient 4 was first treated topically, using antibiotic therapy and painrelievers. The following analyses allowed the treatment to be focused further:
(a) Isotopic ventricular left ejection fraction examination (27 May): 60%,normal.
(b) MRI (28 May): pericardial and left pleural effusion, left ventricularanterior lesion (confirming previous Polish MRI data).
(c) Telethermography (6 June): all the irradiated volumes of the chest wallappeared to be ‘cooler’ and therefore were believed to be prenecrotic.
(d) Bacteriology: persistence of pseudomonas superinfection, despitetreatment with antibiotics.
On 6 June, Patient 4 underwent her first surgical procedure after theoverexposure.15 This procedure consisted of several steps: exploration of the
15 Performed by Dr. Clough, Dr. Couturaud and Prof. Chapelier.
FIG. 23. Patient 4 in May 2002: Local injury before reparative surgery.
Local injury before reparative surgery
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RT Errors - Historical
• Change from physical wedges to Dynamic Wedges (France)
• 2004
• 1 fatality; others with severe complications
• clinic moved from PW to DW; continued to calculate MU for physical wedges resulting in 20-30% overdose
• Taxonomy - Process
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RT Errors - Historical
• Improper jaw size during SRS (France)
• 2004
• normal tissue irradiated; patient developed “fibrosis & oesotracheal fistula” requiring surgery; patient died from “brutal haemorrhage” a few days after surgery
• physicist instructed therapist to set a “40x40” field size, which the therapist interpreted as 40cmx40cm (40mmx40mm)
• Taxonomy - Process
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RT Errors - Historical• Procedure change (Scotland)
• 2005
• 15-year old patient undergoing whole CNS irradiation (brain + spine) received 67% overdose to whole brain due to calculation error
• Patient died 9 months post irradiation - recurrent tumor
• Taxonomy - Process
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RT Errors - Historical
• Commissioning (mis)-measurements (France)
• 2007
• Large chamber used to make small field measurements for SRS
• 200% overdose for some patients
• Taxonomy - Human Error
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RT Errors - HistoricalThe U.S. is not immune...
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RT Errors - Historical• Failure to follow accepted practice/protocol (USA)
• March 2005
• Detailed in NY Times article (“Radiation Boom” series by Walt Bogdanich)
• Plan change after treatment initiation was not “QA’d” in a timely fashion; patient received IMRT MU with NO mlc-modulation (jaws were wide open), resulting in a brutal overdose for 3 fractions
• After suffering from swelling of the brain, loss of sight, loss of hearing, inability to swallow, and finally, difficulty breathing, the patient died of his overdose in 2007
• Same error (mlc retracted) occurred several months later; patient received 6x prescribed dose, but caught after 1 fraction!!!!
• Taxonomy - Process & Human Error at the Physics and Therapist level
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RT Errors - Historical• Failure to implement treatment plan (USA)
• April 2005 (significance with previous case; state inspectors had reinforced need to ensure proper accelerator programming)
• Detailed in NY Times article (“Radiation Boom” series by Walt Bogdanich)
• Physical wedge was either incorrectly positioned or left out entirely, resulting in tissue damage/necrosis of soft tissue, rib, and lung; the resulting burn required a skin/tissue graft and hyperbaric treatment for necrosis; condition lasted for over a year; the patient died several months after the damage from the radiation healed
• Taxonomy - Process & Human Error at the Physics and Therapist level
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RT Errors - Historical• other incidents within New York State reported by the NYT:
• 14-year old girl received double the prescribed dose for 10 treatments (faulty calc, failure to verify)
• 2 prostate cancer patient irradiated to the wrong location 32 of 38 treatments and 19 of 38 treatments (equipment not tested following repairs)
• 31-year old vaginal cancer patient over-dosed by 80%; risk of fistula formation between rectum and vagina (inexperienced team performing IMRT)
• 63-year old patient received >10x the prescribed dose in one location and 1/10th of the prescribed dose in another location
• wrong patient irradiated
• other cases reported in NYT series of articles
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RT Errors - Historical
• SRS unit mis-calibrated (Florida, USA)
• 2005
• 77 brain cancer patients over-dosed by >50% (from 2004 to 2005); disposition of most of the patients was grave due to the disease
• discovered by independent audit by RPC
• Taxonomy - Human Error
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RT Errors - Historical• SRS unit - leakage outside of conical applicator due to incorrect field size
(Illinois, USA) - Toulouse, France anyone?
• 2009
• 4 patients over-dosed to regions of the brain that were not intended to be treated
• 50-year old mother of 3 converted to an invalid (currently in a nursing home, unable to communicate other than “blinking her eyes and squeezing her husband’s hand”) after treatment for a benign condition (TriN)
• After procedure, patient #1 experienced vomiting, burning in her throat, weight loss, and swatches of hair falling out; patient #2 experienced irregular heartbeat, weakness, changes in mental status; patient #3 experienced nausea, vomiting and dehydration (classic ARS of the CNS)
• Taxonomy - Human Error
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RT Errors - Historical
• SRS unit - improperly calibrated using an ion chamber “too large” for the purpose of the measurements (sound familiar, France?)
• 2004-2009
• 76 patients over-dosed by >25-100% (right location, wrong dose)
• results of over-dose varied from facial spasms to balance and memory problems (issues that were reported)
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What does this have to do with me?
• in the span of 22 months between 2007 and 2009, 6 events which required reporting to the state of SC occurred at MRMC (read “misadministration”)
• No patients were injured, but they did not receive “optimal” care
• My platform is now burning...
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Burning Platform
• 2 wrong patients (Tx Delivery)
• 3 wrong sites
• 2 instances where incorrect reference images were generated resulting in the patient being incorrectly setup/irradiated (Planning)
• 1 instance where a pretreatment shift was not performed to the correct area (Tx Delivery)
• 1 instance where a treatment block was incorrect, not detected for 17 fractions (Tx Delivery)
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What do we do?
• engaging our colleagues within Operational Effectiveness (OE), we decided to use Lean principles to analyze the “gap” in our processes
• live by the mantra “we don’t have bad people, just bad processes”
• OE suggested performing a Process-Failure Modes and Effects Analysis
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P-FMEA
• we assembled a multidisciplinary team (physicists, dosimetrists, administrators, therapists, nurses), each with a stake in the process
• we mapped our current processes in as much detail as we could
• for each process step, we identified potential failure modes (91 total)
• each failure mode is scored for Occurrence, Detection, and Severity (scale of 1-10)
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P-FMEA
• Occurrence = 1, rarely happens
• Occurrence = 10, happens all the time
• Detection = 1, easy to see
• Detection = 10, difficult/impossible to see
• Severity = 1, no impact to the patient (perhaps a delay)
• Severity = 10, death/misadministration (our designation)
• Take care to keep scoring “realistic” and “consistent”
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P-FMEA
• for each failure mode, the product of the scores for Occurrence, Detection, and Severity is known as the RPN, or Risk Priority Number (1-1000)
• RPNs can then be sorted in terms of priority for problem solving
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Process Risk Profile Number =Process Risk Profile Number =Process Risk Profile Number =
Category ProcessStep Failure Mode Effect Occurrence
(1-10)Detection
(1-10)Severity
(1-10)Risk Profile
Number
1 Prescription Prescription Written by Oncologist Orders Not Dated - Initial Delay In Treatment 3 1 1 3
2 Prescription Prescription Written by Oncologist Illegible Prescription Prescription Intent Not Carried Out 7 5 10 350
3 Prescription Prescription Written by Oncologist Unclear Prescription (Not enough info) Wrong Treatment 3 1 4 12
4 Prescription Prescription Written by Oncologist No Written Orders Wrong Treatment / Delay In Treatment 3 1 2 6
5 Prescription Prescription Written by Oncologist Unrecognized Changes In Prescription (Date) Delay In Treatment 4 3 4 48
6 Diagnostic Patient Diagnostic Studies Pull Study For Incorrect Patient Incorrect Site 1 5 10 50
7 Diagnostic Patient Diagnostic Studies No Access To Appropriate Study Delay In Treatment 2 1 3 6
8 Diagnostic Patient Diagnostic Studies Delay In Access To Appropriate Study Incorrect Volumes In Treatment 4 2 4 32
9 Immobilize /CT
Immobilization Initial Set-up Inadequate Immobilization Incorrect Treatment / Re-Image / Delay 1 3 7 21
10 Immobilize /CT
Immobilization Initial Set-up Reproducibility Of Set-up Incorrect Treatment / Re-Image / Delay 2 3 5 30
11 Immobilize /CT Planning CT Insufficient Data Re-Image / Delay 1 2 2 4
12 Immobilize /CT Planning CT Inadequate Contrast Studies Incorrect Treatment 3 3 7 63
13 Immobilize /CT Planning CT Nonstandard Patient Orientation Incorrect Treatment / Incorrect Plan/Delay 1 1 10 10
14 Immobilize /CT Planning CT Missing Accessory Re-Image / Delay 1 2 7 14
15 Immobilize /CT Assign Patient Limited Communication Regarding Patient Incorrect Treatment / Delay 4 3 9 108
16 Immobilize /CT
Image Transfer / Patient Creation Call Wrong CT Data Set Incorrect Treatment (Big) 2 9 10 180
17 MD Contour Chart To MD Wrong Data Set Used Incorrect Treatment / Delay In Treatment 1 8 10 80
18 MD Contour Pull Diagnostic Pull Wrong Data Set Incorrect Treatment 1 8 10 80
19 MD Contour Tumor & Targets Inaccurate Volumes Set Increased Side Effects / Delay In Treatment 7 5 7 245
20 MD Contour Tumor & Targets Lack Of Consistency Delay In Treatment 7 2 5 70
21 MD Contour Tumor & Targets Lack Of Clarification Incorrect Treatment / Delay In Treatment 5 10 7 350
22 MD Contour Tumor & Targets No Read back Incorrect Treatment 5 10 7 350
23 DosimetristContour
Contour Normal & Critical Structures Contour Wrong Structure Incorrect Treatment / Increased Side Effects 2 10 10 200
24 DosimetristContour
Contour Normal & Critical Structures Failure To Contour Critical Structure Increased Patient Side Effect 1 5 10 50
25 DosimetristContour Expand MD's Contours Unrealistic Expectations Delay In Treatment 6 1 3 18
26 DosimetristContour Expand MD's Contours Incorrect Margin On Volumes Incorrect Treatment / Delay In Treatment 1 8 3 24
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RPN # Severity > 7 &Detection > 5
Severity > 7Occurence > 5 Original # Category Process
Step Failure Mode Effect
600 2 2 88 Treatment Field Light / Accessory Failure To Detect Error Misadministration / Incorrect Treatment
540 2 2 81 Film Field Check Form Failure To Follow Standard Work Misadministration / Incorrect Treatment
400 2 1 71 Physics DRRs Incorrect Plan Sentinel Event / Misadministration / Delay In Treatment
400 2 1 72 Physics DRRs Incorrect Point Sentinel Event / Misadministration / Delay In Treatment
350 2 2 2 Prescription Prescription Written by Oncologist Illegible Prescription Prescription Intent Not Carried Out
350 2 2 21 MD Contour Tumor & Targets Lack Of Clarification Incorrect Treatment / Delay In Treatment
350 2 2 22 MD Contour Tumor & Targets No Read back Incorrect Treatment
300 2 1 91 Treatment Checks MD Approval Sign Off On Incorrect Plan / Film Misadministration / Incorrect Treatment
270 2 1 30 Planning Isocenter Placement Wrong Placement Sentinel Event / Misadministration / Delay In Treatment
270 2 1 58 Plan Output DRRs To Impac Incorrect Placement Iso Misadministration / Incorrect Treatment / Delay In Treatment
270 2 1 59 Plan Output DRRs To Impac Incorrect Reference Image For MD MD Approves Error - Non Detection
245 2 2 19 MD Contour Tumor & Targets Inaccurate Volumes Set Increased Side Effects / Delay In Treatment
240 2 1 82 Film MD Approval Failure To Detect Error Misadministration / Incorrect Treatment
216 2 1 80 Film Iso Verification /Treatment Fields Failure To Detect Error Misadministration / Incorrect Treatment
200 2 1 23 DosimetristContour
Contour Normal & Critical Structures Contour Wrong Structure Incorrect Treatment / Increased Side Effects
200 2 1 48 Plan Output Print Plan Source Data for iso pair does not match DRR Misadministration/Sentinel Event
200 2 1 51 Plan Output Send To Simulation Send Incorrect Images Misadministration / Incorrect Treatment / Delay In Treatment
200 2 1 53 Plan Output Send To Impac Send Incorrect Images Misadministration / Incorrect Treatment / Delay In Treatment
200 2 1 56 Plan Output DRRs To Impac Send Incorrect Images Misadministration / Incorrect Treatment / Delay In Treatment
200 2 1 74 Physics Verify Iso Coordinates False + Sentinel Event / Misadministration / Delay In Treatment
180 2 1 16 Immobilize /CT
Image Transfer / Patient Creation Call Wrong CT Data Set Incorrect Treatment (Big)
180 2 1 52 Plan Output Send To Simulation Send Incorrect Plan Misadministration / Incorrect Treatment / Delay In Treatment
180 2 1 77 Iso Verification Set-up Marks Incorrect Set-up Marks Incorrect Treatment / Delay In Treatment
180 2 1 78 Iso Verification Daily Shifts Incorrect Shifts (sim) Delay In Treatment
162 2 1 85 Treatment SSDs Failure To Set Correct SSDs Incorrect Treatment
160 2 1 66 Physics Rad Calc Check MU False + Calculation Patient Injury / Delay In Treatment
150 1 2 83 Treatment Patient ID Failure To ID Patient Sentinel Event / Misadministration
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Value of the Work/Data
• From February 2007 to April 2009, 6 misadministrations requiring reporting to the patient and the state
• From April 2009 to now, NO treatment events have been detected or reported (48 months)
• Tracking the perceived impact of process changes on patient safety
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Lean Healthcare - A3 Thinking• named for “A3” paper format for printing - seriously!
• logical extension of the scientific method
• box 1 - Reason for Action
• box 2 - As Is Condition
• box 3 - Desired State
• box 4 - Gap (define the reasons for difference between box 2 and box 3)
• box 5 - Solutions
• box 6 - Rapid Experiments
• box 7 - Completion Plan
• box 8 - Confirmed State
• box 9 - Insights
Monday, April 8, 2013